Irene Romera1, Ramon Gomis2, Susanne Crowe3, Pedro de Pablos-Velasco4, Unai Aranda5, Arantxa García5, Sanja Giljanovic Kis6, Ebrahim Naderali7. 1. Eli Lilly and Company, Avenida de la Industria, 30, 28108 Alcobendas, Madrid, Spain. Electronic address: romerai@lilly.com. 2. Diabetes and Endocrinology Unit, Hospital Clinic de Barcelona, Carrer de Villarroel, 170, 08036, Barcelona, Spain. 3. Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Binger Str. 173, 55218 Ingelheim am Rhein, Germany. 4. Research Institute of Biomedical and Health Sciences (IUIBS), ULPGC. Hospital Universitario de Gran Canaria Dr. Negrín, Barranco de la Ballena, s/n, 35010 Las Palmas de Gran Canaria, Las Palmas, Spain. 5. Boehringer Ingelheim España, S.A., Carrer de Prat de la Riba, 50, 08174 Sant Cugat del Vallès, Barcelona, Spain. 6. Eli Lilly (Suisse) SA Representative Office, Ulica grada Vukovara 269 G Zgrada V2/8. kat 10000, Zagreb, Croatia. 7. Eli Lilly and Company, Lilly House, Priestley Rd, Basingstoke RG24 9NL, UK; Faculty of Science, Liverpool Hope University, Hope Park,Liverpool L16 9JD,Reino Unido, Liverpool, UK.
Abstract
AIMS: This analysis aimed to evaluate efficacy and safety of empagliflozin in combination therapy in <65 y.o. patients, overweight/obese, and with uncontrolled T2DM. METHODS: Pooled analysis from three phase-III trials, in <65 y.o. patients, with BMI 25-35kg/m2, and HbA1c ≥8% at baseline. Patients (N=439) were randomized to placebo (n=138), empagliflozin 10mg (n=160), or empagliflozin 25mg (n=141) once daily (24weeks) as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin. RESULTS: At week 24, adjusted mean (SE) changes from baseline in HbA1c were -0.19% (0.07) for placebo vs. -1.10% (0.07) and -1.10% (0.07) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adjusted mean (SE) changes from baseline in weight were -0.33kg (0.21) for placebo vs. -1.94kg (0.19) and -2.14kg (0.20) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adverse events were reported in 57.2% on placebo, 64.4% on empagliflozin 10mg and 59.6% on empagliflozin 25mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10mg, and 5.0% on empagliflozin 25mg. CONCLUSIONS: In this specific population, empagliflozin in combination with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.
RCT Entities:
AIMS: This analysis aimed to evaluate efficacy and safety of empagliflozin in combination therapy in <65 y.o. patients, overweight/obese, and with uncontrolled T2DM. METHODS: Pooled analysis from three phase-III trials, in <65 y.o. patients, with BMI 25-35kg/m2, and HbA1c ≥8% at baseline. Patients (N=439) were randomized to placebo (n=138), empagliflozin 10mg (n=160), or empagliflozin 25mg (n=141) once daily (24weeks) as add-on to metformin, to metformin plus sulfonylurea, or to pioglitazone ± metformin. RESULTS: At week 24, adjusted mean (SE) changes from baseline in HbA1c were -0.19% (0.07) for placebo vs. -1.10% (0.07) and -1.10% (0.07) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adjusted mean (SE) changes from baseline in weight were -0.33kg (0.21) for placebo vs. -1.94kg (0.19) and -2.14kg (0.20) for empagliflozin 10 and 25mg, respectively (both p<0.001). Adverse events were reported in 57.2% on placebo, 64.4% on empagliflozin 10mg and 59.6% on empagliflozin 25mg. Genital infection AEs were reported in 1.4% on placebo, 3.8% on empagliflozin 10mg, and 5.0% on empagliflozin 25mg. CONCLUSIONS: In this specific population, empagliflozin in combination with other oral agents, significantly reduced HbA1c and body weight and was well tolerated.